Last Updated : May 24, 2023
Details
Generic Name:
maralixibat
Project Status:
Active
Therapeutic Area:
Alagille syndrome
Manufacturer:
Mirum Pharmaceuticals Inc.
Call for patient/clinician input open:
Brand Name:
Livmarli
Project Line:
Reimbursement Review
Project Number:
SR0780-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
For the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) two months of age and older.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | March 23, 2023 |
|---|---|
| Call for patient/clinician input closed | May 15, 2023 |
| Clarification: - Patient input submission received from Alagille Syndrome Alliance and Canadian Liver Foundation | |
| Submission received | May 05, 2023 |
| Submission accepted | May 19, 2023 |
| Review initiated | May 23, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | August 04, 2023 |
| Deadline for sponsors comments | August 16, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | September 15, 2023 |
| Expert committee meeting (initial) | September 27, 2023 |
| Draft recommendation issued to sponsor | October 11, 2023 To October 13, 2023 |
| Draft recommendation posted for stakeholder feedback | October 19, 2023 |
| End of feedback period | November 02, 2023 |
Last Updated : May 24, 2023